510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DOEClass II

Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

21 CFR 862.3640 / Clinical Toxicology
FDA source (opens on fda.gov)

DOE is the FDA product code for Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep., a class II device type, regulated under 21 CFR 862.3640. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DOE
Device name
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Regulation
21 CFR 862.3640
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
0

Clearances, product code DOE

By decision year
12 clearances under product code DOE with a decision year between 1983 and 2001, 2001 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DOE by decision year
YearClearances
19832
19872
19881
19942
19951
20001
20013

Applicants with the most clearances

Product code DOE
Applicants holding the most 510(k) clearances under product code DOE
ApplicantClearances
Roche Diagnostic Systems, Inc.3
Alfa Scientific Designs, Inc.2
Hoffmann-La Roche, Inc.2
Branan Medical Corp.1
Siemens Healthcare Diagnostics Inc.1
Icn Micromedic Systems1
Immunalysis Corporation1
Pan Probe Biotech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code